Local transanal or other resection [1,2] with or without perioperative external-beam radiation therapy (EBRT) plus fluorouracil (5-FU).

There are three potential options for surgical resection in stage I rectal cancer: local excision, LAR, and APR. Local excision should be restricted to tumors confined to the rectal wall and that do not, on rectal ultrasound or magnetic resonance imaging, involve the full thickness of the rectum (i.e., not a T3 tumor). The ideal candidate for local excision has a T1 tumor with well-to-moderate differentiation that occupies less than one-third of the circumference of the bowel wall. Local excision should only be applied to very select patients with T2 tumors, as there is a higher risk of local and systemic failure.

For patients with T1 and T2 tumors, no randomized trials are available to compare local excision with or without postoperative chemoradiation to wide surgical resection (LAR and APR). Investigators with the Cancer and Leukemia Group B (CALGB) enrolled patients with T1 and T2 rectal adenocarcinomas that were within 10 cm of the dentate line and not more than 4 cm in diameter, and involving not more than 40% of the rectal circumference, onto a prospective protocol, CLB-8984. Patients with T1 tumors received no additional treatment following surgery, whereas patients with T2 tumors were treated with EBRT (54 Gy of 30 fractions, 5 days/week) and 5-FU (500 mg/m2 on days 1 through 2 and days 29 through 31 of radiation). At 48 months median follow-up, the 6-year failure-free survival and overall survival (OS) rates for patients with T1 tumors were 83% and 87%, respectively. For patients with T2 tumors, the 6-year failure-free survival and OS rates were 71% and 85%, respectively.[3]

Patients with tumors that are pathologically T1 may not need postoperative therapy. Patients with tumors that are T2 or greater have lymph node involvement about 20% of the time, and additional therapy should be considered, such as radiation and chemotherapy, or more standard surgical resection.[4] Patients with poor histologic features or positive margins after local excision should consider LAR or APR and postoperative treatment as dictated by full surgical staging.

Current Clinical Trials

Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with stage I rectal cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

This information is produced and provided by the National Cancer Institute (NCI). The information in this topic may have changed since it was written. For the most current information, contact the National Cancer Institute via the Internet web site at http://cancer.gov or call 1-800-4-CANCER

This information is not intended to replace the advice of a doctor. Healthwise disclaims any liability for the decisions you make based on this information.

Some material in CancerNet™ is from copyrighted publications of the respective copyright claimants. Users of CancerNet™ are referred to the publication data appearing in the bibliographic citations, as well as to the copyright notices appearing in the original publication, all of which are hereby incorporated by reference.